Effect of Listening to Standardized Music Sequences on Preventing Postoperative Pain in Proctologic Surgery
NCT ID: NCT06798155
Last Updated: 2025-06-26
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
550 participants
INTERVENTIONAL
2025-02-03
2027-07-31
Brief Summary
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This research will assess the influence of preoperative music on postoperative pain management, the use of analgesics after surgery and during the following month, and its effect on the quality of life post-surgery.
MUSICO-PROCTO is an interventional, randomized study involving two groups (patients will be randomly assigned to either the music intervention or control group). The study is monocentric, conducted at Clinique Saint Vincent in France, and includes 550 participants.
Participants will be followed for 28 days, while the overall study duration will span 28 months.
To participate, individuals must:
Be aged 18 or older. Be affiliated with a social security system. Provide signed informed consent. Undergo proctologic surgery for hemorrhoids, fistulas, or anal fissures. This study seeks to explore the potential of music as a complementary method to improve postoperative outcomes.
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
SUPPORTIVE_CARE
NONE
Study Groups
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Standardized Music Listening
Participants assigned to this arm will benefit from standardized music listening sessions via the Music Care® application.
Pre-surgery: At the entrance to the operating room, participants will spend 20 minutes lying on a stretcher in a dedicated room, listening to relaxing music sequences through a tablet and headphones provided by the research team. Participants can select their preferred musical style, tempo, and tracks.
Post-surgery: Participants will continue listening to music sequences daily for 20 minutes at home using their own devices (smartphone, tablet, or computer) until day 28 post-surgery.
Standardized Music Listening Therapy
Type of Intervention: Pre- and postoperative listening to standardized music sequences designed specifically for relaxation and pain management.
Delivery Method: Sessions are conducted via the Music Care® application, using a tablet and headphones provided during hospitalization. Participants select their preferred music style, tempo, and tracks to tailor the experience to their preferences.
Duration and Schedule:
Pre-surgery: One 20-minute session in a dedicated room before entering the operating theater.
Post-surgery: Daily 20-minute sessions at home for 28 days post-surgery using participants' own devices (smartphone, tablet, or computer).
Purpose: To evaluate the effect of music on reducing postoperative pain, minimizing analgesic use, and improving the quality of life.
Distinctiveness: This intervention uniquely integrates patient-controlled music preferences with a structured listening regimen before and after surgery, offering a personalized approach to enhancing recovery outcom
Standard Care
Participants assigned to this arm will not benefit from standardized music listening sessions.
Pre-surgery: Participants will proceed directly from their hospital room to the operating room without a music listening session.
Post-surgery: Participants will be managed according to standard care practices, with no additional interventions related to music therapy.
No interventions assigned to this group
Interventions
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Standardized Music Listening Therapy
Type of Intervention: Pre- and postoperative listening to standardized music sequences designed specifically for relaxation and pain management.
Delivery Method: Sessions are conducted via the Music Care® application, using a tablet and headphones provided during hospitalization. Participants select their preferred music style, tempo, and tracks to tailor the experience to their preferences.
Duration and Schedule:
Pre-surgery: One 20-minute session in a dedicated room before entering the operating theater.
Post-surgery: Daily 20-minute sessions at home for 28 days post-surgery using participants' own devices (smartphone, tablet, or computer).
Purpose: To evaluate the effect of music on reducing postoperative pain, minimizing analgesic use, and improving the quality of life.
Distinctiveness: This intervention uniquely integrates patient-controlled music preferences with a structured listening regimen before and after surgery, offering a personalized approach to enhancing recovery outcom
Eligibility Criteria
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Inclusion Criteria
* Patient who has signed an informed consent form.
* Patient scheduled to undergo proctological surgery (for hemorrhoids, fistula, or anal fissure) at the participating institution.
* Must be affiliated with a social security system or be a beneficiary of such a system.
* Patient must have access to the necessary technical means (smartphone, computer, tablet) to use the Music Care® application.
Exclusion Criteria
* Patient unable to read, write, or understand French.
* Vulnerable patient according to Article L1121-6 of the French Public Health Code (CSP).
* Adult patient under guardianship or curatorship or under legal protection (safeguard of justice).
* Patient unable to personally give informed consent according to Article L.1121-8 of the CSP or an adult protected by law.
* Pregnant or breastfeeding women according to Article L1121-5 of the CSP.
* Patient who has already participated in a study within the last 12 months.
18 Years
ALL
No
Sponsors
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Clinique Saint-Vincent
OTHER
Responsible Party
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Locations
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Clinique Saint Vincent
Saint-Denis, , Reunion
Clinique Saint Vincent
Saint-Denis, , Reunion
Countries
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Central Contacts
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Facility Contacts
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Related Links
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Related Info
Other Identifiers
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24.04190.000403
Identifier Type: -
Identifier Source: org_study_id
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